RecruitingPhase 1Phase 2NCT06081686

Study of [177Lu] Lu-XT033 Injection in Patients With Metastatic Prostate Cancer

Phase I/II Study to Evaluate the Safety and Tolerability, Radiation Dosimetry and Pharmacokinetics, and Efficacy of [177Lu] Lu-XT033 Injection in Patients With Metastatic Prostate Cancer

Sponsor

Sinotau Pharmaceutical Group

Enrollment

32 participants

Start Date

Sep 13, 2023

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

Summary

This was a multicenter, open-label, phase I/II study to evaluate the safety and tolerability, radiation dosimetry and pharmacokinetic characteristics, and efficacy of \[177Lu\] Lu-XT033 injection in patients with metastatic prostate cancer, including a phase I study and a phase II extension study.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a radioactive treatment called Lu-XT033 in men with metastatic prostate cancer that no longer responds to hormone therapy (called castration-resistant prostate cancer). The treatment delivers radiation directly to prostate cancer cells using a targeted molecule. **You may be eligible if...** - You are a man between 18 and 80 years old - You have prostate cancer confirmed by biopsy that has spread (metastatic) - Your cancer is castration-resistant (testosterone is very low but cancer is still growing) - A special PET/CT scan (PSMA scan) shows your cancer can be detected by this imaging method - You have already been treated with at least one hormone-blocking drug and 1-2 rounds of chemotherapy - Your overall health and organ function are adequate **You may NOT be eligible if...** - You have received certain radioactive bone treatments or previous PSMA-targeted therapy in the past 6 months - Your cancer has spread to the brain (CNS metastases) - You have another active cancer - You have had recent major cancer treatment (within 28 days) - You have serious heart problems or active infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPhase I:[177Lu]Lu-XT033 Injection

Six subjects were enrolled in the 1.11 Gbq (30 mCi) group of \[177Lu\] Lu-XT033 Injection. The last subject in this group completed the 4-week observation period after the first dose, With the consent of the Safety Monitoring Committee (SRC), 6 subjects were enrolled in the 1.85 Gbq (50 mCi) group. Both groups used 8 ± 1 weeks as the dosing interval .

DRUGPhase II:[177Lu]Lu-XT033 Injection

Patients received \[177Lu\]Lu-XT033 Injection every 8 weeks (+/- 1 week) for a maximum of 6 cycles.

Locations(2)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06081686

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